Device product
Integra Jarit GEMINI CLAMP 9 1/4 inch - used in vascular and cardiothoracic procedures used for clamping and occluding vessels. Cat. #140-332
Z-2435-2019
Product summary
- Event
- Event 83418
- Status
- Terminated
- Classification
- Class II
- Quantity
- 237 units
- Official record key
device-enforcement:Z-2435-2019
Official wording
Reason: A small crack at the box lock corner may after multiple cleaning and sterilization cycles produce an increased risk of corrosion, weakening the instrument and resulting in premature need for replacement and/or breakage of the instrument
Code information: Lot #AA1901
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
A small crack at the box lock corner may after multiple cleaning and sterilization cycles produce an increased risk of corrosion, weakening the instrument and resulting in premature need for replacement and/or breakage of the instrument